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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01797965
Registration number
NCT01797965
Ethics application status
Date submitted
15/02/2013
Date registered
25/02/2013
Date last updated
4/12/2019
Titles & IDs
Public title
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
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Scientific title
A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
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Secondary ID [1]
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2012-003176-39
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Secondary ID [2]
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205MS303
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Universal Trial Number (UTN)
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Trial acronym
EXTEND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIIB019 (Daclizumab)
Experimental: BIIB019 - BIIB019 150 mg subcutaneous (SC) every 4 weeks
Treatment: Drugs: BIIB019 (Daclizumab)
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
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Timepoint [1]
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First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
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Secondary outcome [1]
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Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period
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Assessment method [1]
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Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 205MS301, calculated using the negative binomial model.
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Timepoint [1]
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Up to 4.6 years in the 303 study
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Secondary outcome [2]
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ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period
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Assessment method [2]
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Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 301, calculated using the negative binomial model.
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Timepoint [2]
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Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study
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Secondary outcome [3]
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Number of Participants With Relapse in the 205MS303 Treatment Period
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Assessment method [3]
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Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.
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Timepoint [3]
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Up to 4.6 years in the 303 study
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Secondary outcome [4]
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Number of Participants With Relapse in the 205MS301-303 Combined Study Period
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Assessment method [4]
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Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.
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Timepoint [4]
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Up to 5.6 years combining 303 with the initial Study 301
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Secondary outcome [5]
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Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period
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Assessment method [5]
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Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS =1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.
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Timepoint [5]
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Up to 4.6 years in Study 303
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Secondary outcome [6]
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Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
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Assessment method [6]
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Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS =1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.
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Timepoint [6]
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Up to 5.6 years combining 303 with the initial Study 301
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Secondary outcome [7]
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Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period
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Assessment method [7]
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T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.
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Timepoint [7]
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Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
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Secondary outcome [8]
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Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period
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Assessment method [8]
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T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported.
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Timepoint [8]
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Baseline 301, Weeks 24, 96, 144 in Study 301
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Secondary outcome [9]
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Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period
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Assessment method [9]
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Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.
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Timepoint [9]
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301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96
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Secondary outcome [10]
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Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period
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Assessment method [10]
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Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.
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Timepoint [10]
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Baseline 301, Weeks 24, 96 and 144
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Secondary outcome [11]
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Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period
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Assessment method [11]
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T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.
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Timepoint [11]
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Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
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Secondary outcome [12]
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Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period
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Assessment method [12]
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T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported .
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Timepoint [12]
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Baseline 301, Weeks 24, 96, 144 in Study 301
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Secondary outcome [13]
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Percent Change in Brain Volume From the 205MS303 Baseline
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Assessment method [13]
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To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.
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Timepoint [13]
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Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
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Secondary outcome [14]
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Percent Change in Brain Volume From 205MS301 Baseline
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Assessment method [14]
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To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.
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Timepoint [14]
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Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303
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Secondary outcome [15]
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Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period
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Assessment method [15]
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Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader.
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Timepoint [15]
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Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96
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Secondary outcome [16]
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Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period
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Assessment method [16]
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MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement.
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Timepoint [16]
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Baseline 303, Weeks 12, 24 and 48 in Study 303
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Secondary outcome [17]
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Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period
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Assessment method [17]
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MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement.
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Timepoint [17]
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Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study
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Secondary outcome [18]
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Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period
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Assessment method [18]
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The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 0=normal neurologic exam; to 5=ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to 10=death due to MS. Higher scores indicate more disability. A negative change from Baseline indicates improvement.
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Timepoint [18]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303
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Secondary outcome [19]
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Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period
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Assessment method [19]
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Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions.
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Timepoint [19]
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Up to 4.6 years in Study 303
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Secondary outcome [20]
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Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period
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Assessment method [20]
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The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement.
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Timepoint [20]
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Baseline 303, Weeks 12, 24, 48, 96, 120 and 144
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Secondary outcome [21]
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Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period
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Assessment method [21]
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The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement.
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Timepoint [21]
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301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
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Secondary outcome [22]
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Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period
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Assessment method [22]
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The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement.
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Timepoint [22]
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301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
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Secondary outcome [23]
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Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period
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Assessment method [23]
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Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.
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Timepoint [23]
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301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303
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Secondary outcome [24]
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Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period
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Assessment method [24]
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Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.
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Timepoint [24]
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Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301
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Secondary outcome [25]
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Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period
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Assessment method [25]
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Participants answered the question: "How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition?" using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported.
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Timepoint [25]
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Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303
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Secondary outcome [26]
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Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period
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Assessment method [26]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment.
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Timepoint [26]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [27]
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HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period
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Assessment method [27]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment.
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Timepoint [27]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [28]
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HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period
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Assessment method [28]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment.
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Timepoint [28]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [29]
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HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period
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Assessment method [29]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment.
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Timepoint [29]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [30]
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HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period
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Assessment method [30]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores.
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Timepoint [30]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [31]
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HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period
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Assessment method [31]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores.
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Timepoint [31]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [32]
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HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period
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Assessment method [32]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments.
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Timepoint [32]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [33]
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HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period
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Assessment method [33]
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The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything.
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Timepoint [33]
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301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
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Secondary outcome [34]
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Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period
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Assessment method [34]
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Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant.
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Timepoint [34]
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Up to 4.6 years in 303
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Secondary outcome [35]
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Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS
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Assessment method [35]
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The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.
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Timepoint [35]
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After the first and fourth injections in 303, approximately Week 0 and Week 12
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Secondary outcome [36]
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Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories
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Assessment method [36]
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The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported.
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Timepoint [36]
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After the first and fourth injections in 303, approximately Week 0 and Week 12
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Secondary outcome [37]
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Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period
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Assessment method [37]
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Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported.
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Timepoint [37]
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Up to 4.6 years in the 303 Treatment Period
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Secondary outcome [38]
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Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period
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Assessment method [38]
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Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported.
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Timepoint [38]
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Up to 4.6 years in the 303 Treatment Period
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Secondary outcome [39]
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Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period
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Assessment method [39]
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SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement.
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Timepoint [39]
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Baseline 303, Weeks 144, 168, 192, 240 in 303
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Secondary outcome [40]
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Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period
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Assessment method [40]
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SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement.
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Timepoint [40]
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Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303
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Secondary outcome [41]
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0
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period
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Assessment method [41]
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The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.
Query!
Timepoint [41]
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0
Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303
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Secondary outcome [42]
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0
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period
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Assessment method [42]
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The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.
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Timepoint [42]
0
0
Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study
Query!
Eligibility
Key inclusion criteria
Key
* Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later).
* Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
* Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/02/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/09/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1501
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Auchenflower
Query!
Recruitment hospital [2]
0
0
Research Site - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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0
0
United States of America
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State/province [2]
0
0
Arkansas
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0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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0
0
United States of America
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State/province [5]
0
0
Florida
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0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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0
0
United States of America
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State/province [8]
0
0
Kansas
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0
0
United States of America
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State/province [9]
0
0
Kentucky
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0
0
United States of America
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State/province [10]
0
0
Massachusetts
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0
0
United States of America
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State/province [11]
0
0
Michigan
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0
0
United States of America
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0
0
New Hampshire
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0
0
United States of America
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0
0
New Mexico
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0
0
United States of America
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0
0
New York
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0
0
United States of America
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0
0
North Carolina
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0
0
United States of America
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Ohio
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0
United States of America
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Oregon
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0
United States of America
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0
0
Pennsylvania
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0
0
United States of America
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0
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Tennessee
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0
0
United States of America
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0
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Texas
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0
0
United States of America
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0
0
Virginia
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0
0
United States of America
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0
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Washington
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0
0
United States of America
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0
0
Wisconsin
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0
0
Argentina
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0
0
Buenos Aires
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Argentina
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Mendoza
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0
0
Argentina
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0
0
Santa Fe
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0
0
Brazil
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0
0
Minas Gerais
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0
0
Brazil
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0
0
Pernambuco
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0
0
Brazil
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0
0
Rio Grande Do Sul
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0
0
Brazil
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0
0
São Paulo
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0
0
Brazil
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State/province [31]
0
0
Rio de Janeiro
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0
0
Brazil
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0
0
Rio De Janeiro
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0
0
Canada
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0
0
British Columbia
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0
0
Canada
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0
0
Newfoundland and Labrador
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0
0
Canada
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0
0
Ontario
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0
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Canada
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0
0
Quebec
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0
0
Czechia
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Jihomoravský Kraj
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Czechia
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Kray Vysocina
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Czechia
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Moravskoslezský Kraj
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Czechia
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Pardubický Kraj
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Czechia
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Praha
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Czechia
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Severomoravsky Kraj
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Czechia
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Hradec Kralove
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Czechia
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Praha 5
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Czechia
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Ústecký Kraj
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0
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Denmark
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Copenhagen
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0
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Denmark
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Glostrup
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0
0
Denmark
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0
0
Odense C
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0
0
France
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Bas-Rhin
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France
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0
Bouches-du-Rhône
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0
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France
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0
0
Calvados
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0
0
France
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Gironde
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0
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France
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Haute-Garonne
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0
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France
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Ile-de-France
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0
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France
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Meurthe-et-Moselle
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0
0
France
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State/province [56]
0
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Nord
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Country [57]
0
0
France
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State/province [57]
0
0
Amiens Cedex 1
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Country [58]
0
0
France
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0
0
Paris
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Country [59]
0
0
Georgia
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0
0
Tbilisi
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0
0
Germany
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0
Baden-Württemberg
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0
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Germany
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Bayern
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Germany
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Hessen
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Country [63]
0
0
Germany
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0
Mecklenburg-Vorpommern
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0
0
Germany
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0
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Sachsen
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0
0
Germany
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State/province [65]
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Bamberg
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Country [66]
0
0
Greece
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Attiki
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Country [67]
0
0
Greece
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State/province [67]
0
0
Macedonia
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Country [68]
0
0
Greece
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State/province [68]
0
0
Athens
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Country [69]
0
0
Greece
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State/province [69]
0
0
Thessaloniki
Query!
Country [70]
0
0
Hungary
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State/province [70]
0
0
Borsod-Abaúj-Zemplén
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Bács-Kiskun
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Fejer
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Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Balatonfüred
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Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Budapest
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Country [75]
0
0
Hungary
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State/province [75]
0
0
Debrecen
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Country [76]
0
0
Hungary
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State/province [76]
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0
Esztergom
Query!
Country [77]
0
0
Hungary
Query!
State/province [77]
0
0
Gyor
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Country [78]
0
0
Hungary
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State/province [78]
0
0
Miskolc
Query!
Country [79]
0
0
Hungary
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State/province [79]
0
0
Nyíregyháza
Query!
Country [80]
0
0
India
Query!
State/province [80]
0
0
Andhra Pradesh
Query!
Country [81]
0
0
India
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State/province [81]
0
0
Karnataka
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Country [82]
0
0
India
Query!
State/province [82]
0
0
Kerala
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Country [83]
0
0
India
Query!
State/province [83]
0
0
Maharashtra
Query!
Country [84]
0
0
India
Query!
State/province [84]
0
0
Gurgaon
Query!
Country [85]
0
0
Ireland
Query!
State/province [85]
0
0
Dublin
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Country [86]
0
0
Israel
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State/province [86]
0
0
Ashkelon
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Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Haifa
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Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Petah Tikva
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Safed
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Liguria
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Country [91]
0
0
Italy
Query!
State/province [91]
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0
Lombardia
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Veneto
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Country [93]
0
0
Italy
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State/province [93]
0
0
Catania
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Country [94]
0
0
Italy
Query!
State/province [94]
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0
Cefalù
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Country [95]
0
0
Italy
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State/province [95]
0
0
Roma
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Country [96]
0
0
Mexico
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State/province [96]
0
0
Distrito Federal
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Country [97]
0
0
Moldova, Republic of
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State/province [97]
0
0
Chisinau
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Country [98]
0
0
Poland
Query!
State/province [98]
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0
Kujawsko-pomorskie
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0
0
Poland
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0
Lubelskie
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0
Poland
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Lódzkie
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0
Poland
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Malopolskie
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0
Poland
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0
Mazowieckie
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Poland
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0
Podlaskie
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0
0
Poland
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0
Pomorskie
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0
0
Poland
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0
0
Slaskie
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0
Poland
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0
Swietokrzyskie
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Poland
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Warminsko-mazurskie
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Poland
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Wielkopolskie
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0
Poland
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State/province [109]
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0
Zachodniopomorskie
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0
0
Poland
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Gdansk
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0
Poland
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State/province [111]
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Grudziadz
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Poland
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Katowice
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Poland
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State/province [113]
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Olsztyn
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Romania
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Cluj
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0
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Romania
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Mures
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0
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Romania
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Timis
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0
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Romania
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Bucharest
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Romania
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Iasi
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Russian Federation
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Yaroslavlr
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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0
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Russian Federation
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Krasnoyarsk
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0
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Russian Federation
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Moscow
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0
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Russian Federation
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Nizhny Novgorod
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0
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Russian Federation
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Novosibirsk
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0
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Russian Federation
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Omsk
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0
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Russian Federation
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0
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Perm
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0
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Russian Federation
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Samara
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0
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Russian Federation
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Smolensk
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0
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Russian Federation
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0
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St. Petersburg
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0
0
Russian Federation
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Tyumen
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0
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Russian Federation
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0
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Ufa
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Country [133]
0
0
Serbia
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0
0
Belgrade
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0
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Serbia
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Kragujevac
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0
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Serbia
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State/province [135]
0
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Nis
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0
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Serbia
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0
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Novi Sad
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Country [137]
0
0
Spain
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Barcelona
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Country [138]
0
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Spain
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0
Córdoba
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Country [139]
0
0
Spain
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State/province [139]
0
0
Madrid, Communidad Delaware
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Country [140]
0
0
Spain
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State/province [140]
0
0
Girona
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Country [141]
0
0
Spain
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State/province [141]
0
0
l'Hospitalet de Llobregat
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Country [142]
0
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Spain
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State/province [142]
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Sevilla
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Country [143]
0
0
Sweden
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Skane
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Country [144]
0
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Sweden
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State/province [144]
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0
Sodermanlands Lan
Query!
Country [145]
0
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Sweden
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State/province [145]
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Vastra Gotalands Lan
Query!
Country [146]
0
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Sweden
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Stockholm
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Country [147]
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Switzerland
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State/province [147]
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Basel-Stadt (de)
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Country [148]
0
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Ukraine
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State/province [148]
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0
Chernivets'ka Oblast
Query!
Country [149]
0
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Ukraine
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State/province [149]
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0
Dnipropetrovs'ka Oblast'
Query!
Country [150]
0
0
Ukraine
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State/province [150]
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0
Donets'ka Oblast'
Query!
Country [151]
0
0
Ukraine
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State/province [151]
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0
Kharkivs'ka Oblast'
Query!
Country [152]
0
0
Ukraine
Query!
State/province [152]
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0
Kyïv
Query!
Country [153]
0
0
Ukraine
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State/province [153]
0
0
Odes'ka Oblast
Query!
Country [154]
0
0
Ukraine
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State/province [154]
0
0
Poltavs'ka Oblast
Query!
Country [155]
0
0
Ukraine
Query!
State/province [155]
0
0
Vinnyts'ka Oblast'
Query!
Country [156]
0
0
Ukraine
Query!
State/province [156]
0
0
Zaporiz'ka Oblast'
Query!
Country [157]
0
0
Ukraine
Query!
State/province [157]
0
0
Zaporizhia Oblast
Query!
Country [158]
0
0
Ukraine
Query!
State/province [158]
0
0
Kharkiv
Query!
Country [159]
0
0
United Kingdom
Query!
State/province [159]
0
0
Devon
Query!
Country [160]
0
0
United Kingdom
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State/province [160]
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Edinburgh, City Of
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United Kingdom
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Brighton
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Biogen
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Commercial sector/industry
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AbbVie
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Ethics approval
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Summary
Brief summary
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon ß-1a (Avonex) in Study 205MS301(NCT01064401).
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Trial website
https://clinicaltrials.gov/study/NCT01797965
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Trial related presentations / publications
Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
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Public notes
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Contacts
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Medical Director
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Biogen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/65/NCT01797965/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/65/NCT01797965/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01797965
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